募集要項
- 募集背景
- A global drug development company is looking for a Regulatory Affairs Director. The qualified applicant will be leading strategic regulatory consulting projects, maintaining key communications, overseeing preparation and submission of regulatory documents, and ensuring the timely advancement of projects. This is a remote setup role.
- 仕事内容
-
A global drug development company is looking for a Regulatory Affairs Director.Responsibilities:
* Establish and maintain communications between management, clients, and Key Opinion Leaders
* Define, delegate, and manage the activities of direct reports as well as other staff and external consultants
* Maintain communications with Japanese and other Asian regulatory authorities to gain endorsement for development strategies
* Oversee preparation, review, QC/ finalisation, and submission of regulatory documents
* Ensure the timely advancement of projects from the stage of regulatory strategy development through clinical trial implementation
* Communicate business model to potential clients
Requirements:
* Bachelor's degree or above
* Practical experience in communicating with PMDA
* Prior line management experience to Regulatory Affairs members
* Adaptability and versatility to changing tasks as required by ongoing projects
* Strong interpersonal communication skills
* Business level English and Japanese
- 応募資格
-
- 必須
-
Practical experience in communicating with PMDA
- 歓迎
-
Prior line management experience to Regulatory Affairs members
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY12,000,000.00 - JPY18,000,000.00 per annum
- 休日休暇
- weekends off, public holidays, paid holidays